ZEGERID OTC - omeprazole and sodium bicarbonate capsule 
RILEY CONSUMER CARE, LLC

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Drug Facts

Active ingredients (in each capsule)

Omeprazole 20 mg
Sodium Bicarbonate 1100 mg

Purpose

Acid reducer
Allows absorption of this omeprazole product

Use

Warnings

Allergy alert: 

•   do not use if you are allergic to omeprazole.

•   omeprazole may cause severe skin reactions.

Symptoms may include:

     •  skin reddening
     •  blisters
     •  rash
If an allergic reaction occurs, stop use and seek medical help right away.

Do not use if you have:

These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are taking a prescription drug.

Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

14-Day Course of Treatment

Repeated 14-Day Courses (if needed)

Other information

Inactive ingredients

citric acid anhydrous, croscarmellose sodium, FD&C blue #1 aluminum lake, gelatin, magnesium stearate, polysorbate 80, potassium sorbate, propylene glycol, shellac, sodium lauryl sulphate and titanium dioxide.

Questions or comments?

Call 1-888-4-ZEG-OTC (1-888-493-4682) between 9:00 AM and 5:00 PM Eastern Standard Time, Monday through Friday

HOW ZEGERID OTC WORKS FOR YOUR FREQUENT HEARTBURN

Zegerid OTC works differently from other OTC heartburn products, such as antacids and other acid reducers. Zegerid OTC stops acid production at the source - the acid pump that produces stomach acid. Zegerid OTC is to be used once a day (every 24 hours), every day for 14 days.


TIPS FOR MANAGING HEARTBURN


Dist by:
Riley Consumer Care, LLC
d/b/a Carlin
Consumer Health
New York, NY 10151

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/1100 mg (14 Capsules Container Label)

CLINICALLY PROVEN TO
Treat Frequent Heartburn

Zegerid
OTC®


•    
Omeprazole 20 mg/Acid Reducer
•    Sodium Bicarbonate 1100 mg

        
/Allows Absorption of this
        Omeprazole Product


14
CAPSULES
ONE 14-DAY COURSE OF TREATMENT



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/1100 mg (14 Capsules Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/1100 mg (14 Capsules Container Carton Label)

CLINICALLY PROVEN TO
Treat Frequent Heartburn

Zegerid
OTC®

•    
Omeprazole 20 mg/Acid Reducer
•    Sodium Bicarbonate 1100 mg

     
  /Allows Absorption of this
      Omeprazole Product


24 HOUR

14
CAPSULES
One 14-Day Course of Treatment
MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/1100 mg (14 Capsules Container Label)



ZEGERID OTC 
omeprazole and sodium bicarbonate capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82632-101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1100 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (Blue band) Scoreno score
ShapeCAPSULESize24mm
FlavorImprint Code ZEG
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82632-101-011 in 1 CARTON12/22/2023
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:82632-101-033 in 1 CARTON12/22/2023
214 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20492312/22/2023
Labeler - RILEY CONSUMER CARE, LLC (118598784)
Registrant - Aurohealth LLC (078728447)

Revised: 4/2024
Document Id: dfed6561-212a-4afa-a929-4d80cdfcdef3
Set id: dfed6561-212a-4afa-a929-4d80cdfcdef3
Version: 1
Effective Time: 20240420
 
RILEY CONSUMER CARE, LLC